Transaortic transcatheter aortic valve implantation - rationale and design of the multicenter, multinational prospective ROUTE registry.

Abstract

BACKGROUND:

Transaortic transcatheter aortic valve implantation (TAo-TAVI) is a recently developed approach that provides an alternative delivery route for valve replacement in patients with vascular abnormalities or existing comorbidities. While initial studies have shown the principal efficacy and safety, the real world effectiveness and safety of this approach remains to be fully assessed.

METHODS/DESIGN:

In this regard, the Registry Of the Utilization of the TAo-TAVI approach using the Edwards SAPIEN Valve (ROUTE) represents the first multicenter, multinational prospective documentation of the course and outcome of patients with severe calcific aortic stenosis (AS) undergoing TAo-TAVI. ROUTE commenced in February 2013 with the goal of consecutively enrolling 300 patients at up to 22 sites across Europe. The primary objective of ROUTE is to determine the 30-day mortality associated with TAo-TAVI using the Edwards SAPIEN THV (Edwards Lifesciences, Irvine, CA). In addition, ROUTE aims to quantify complications, predictors of patient outcome and the value of CT guided valve sizing.

DISCUSSION:

Findings from this landmark registry will provide important information regarding procedural success rates and early mortality in patients undergoing TAo-TAVI.

TRIAL REGISTRATION:

Identifier: NCT01991431.

• Authors: Peter Bramlage, Mauro Romano, Nikolaos Bonaros, Ricardo Cocchieri, Dariusz Jagielak, Derk Frank, Vinayak Bapat
• Journal: BMC cardiovascular disorders (BMC Cardiovasc Disord) Vol. 14 Pg. 152 (Nov 01 2014) ISSN: 1471-2261 [Electronic] England
• PMID: 25361564 (Publication Type: Journal Article, Multicenter Study, Observational Study, Research Support, Non-U.S. Gov't)

Topics

• Aortic Valve (pathology)
• Aortic Valve Stenosis (diagnosis, mortality, therapy)
• Calcinosis (diagnosis, mortality, therapy)
• Cardiac Catheterization (adverse effects, instrumentation, mortality)
• Europe
• Heart Valve Prosthesis
• Heart Valve Prosthesis Implantation (adverse effects, instrumentation, methods, mortality)
• Humans
• Prospective Studies
• Prosthesis Design
• Registries
• Research Design
• Risk Assessment
• Risk Factors
• Severity of Illness Index
• Time Factors
• Treatment Outcome